Adverse Events Module

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Adverse Events Module

For researchers submitting trial data to ClinicalTrials.gov, the Adverse Events module is one of four mandatory results sections. It requires reporting in three primary categories: All-Cause Mortality: A table tracking all deaths that occurred during the study, regardless of cause. Serious Adverse Events (SAEs): A tabular summary of events resulting in death, life-threatening conditions, hospitalization, or significant disability. Other Adverse Events: A table for non-serious events that exceed a specific frequency threshold, such as 5% within any study arm.

Adverse Events Module path is as follows:

Study -> Results Section -> Adverse Events Module -> Event Groups

Study -> Results Section -> Adverse Events Module -> Serious Events

Study -> Results Section -> Adverse Events Module -> Other Events

Adverse Events Module

Ignite Creation Date: 2025-12-24 @ 11:38 PM
Ignite Modification Date: 2025-12-25 @ 9:28 PM
NCT ID: NCT02100956
Description: Peripheral oxyhemoglobin saturation, blood pressure, and heart rate were measured non invasively and recorded before and 15, 30, 60, 120, 180, 240, minutes after intrathecal injection. The electrocardiogram was continuously monitored. A neurologic examination was performed at intervals until 24 hours after injection. Serum sodium was assayed 24 hr after injection. Subjects were called 2, 3, 4, 5, 7 days, then weekly until one month and then at 6 months after the second intrathecal injection.
Frequency Threshold: 5
Time Frame: 6 months after second intrathecal injection, up to 6.5 months
Study: NCT02100956
Study Brief: Efficacy of Intrathecal Oxytocin in Patients With Neuropathic Pain
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Oxytocin Injection Participants who received intrathecal oxytocin injection on either the first or second study day 0 None 0 6 0 6 View
Placebo Injection Patients who received normal saline placebo injection on either the first or second study day. 0 None 0 6 1 6 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Post dural puncture headache NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View